ZeroPM Regulatory Watch Update May 2024

Commission adopts criteria and principles for defining ‘essential uses’ of hazardous chemicals

Announced in the Chemical Strategy for Sustainability in 2020, the Communication defining ‘guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals’ was published by the Commission on 22 April 2024. The communication defines that ‘the use of a most harmful substance is essential for society if that use is necessary for health or safety or is critical for the functioning of society and there are no acceptable alternatives’. These might cover critical uses in a wide range of sectors such as healthcare, energy, transport, water and waste treatment, digital communication, defence, disaster management, environmental protection, scientific research or cultural heritage protection. The definition applies to substances that are CMR 1A or 1B, endocrine disruptors for human health and the environment (category 1), respiratory sensitisers (category 1), toxic to specific organs after repeated exposure (category 1), PBT/vPvB, hazardous to the ozone layer (category 1), and subject to further assessment to PMT/vPvM. The essential use concept will only have legal effect when introduced into specific legislation. The Communication does not specify in which legislation the concept will be or should be introduced or how this assessment will be integrated into decision-making.

European Parliament proposes a different soil monitoring approach and the establishment of a watchlist of soil contaminants in its resolution on the Soil Monitoring Directive

The European Parliament adopted its resolution on the Soil Monitoring Directive on 10 April 2024. The Parliament proposes a gradual approach to the assessment of soil health (where the Commission proposal classified soils as healthy or unhealthy), which is based on a five-level classification for the ecological status of soils: high, good, moderate, degraded and critically degraded. Only soils with good or high ecological status would be considered healthy. The Parliament proposes a soil monitoring system according to three tiers, each including a range of soil descriptors. Member States have the autonomy to select the most appropriate tier but would have to include at a minimum all soil descriptors from Tier 1. Regarding soil contamination, Tier 1 includes the monitoring of heavy metals in soil, the concentrations of organic contaminants selected by Member States (taking into account substances covered by the POPs Regulation and existing concentration limits in water and air defined by EU legislation), plant protection product candidates for substitution and substances authorised under emergency regime, biocide residues and PFAS (Sum of PFAS or PFAS total).

Based on monitoring carried out by Member States, the Parliament also proposes the establishment of a list of priority substances, followed by a watchlist of soil contaminants, mirroring existing mechanisms for surface and groundwater, to improve data on contaminants when they are insufficient. Regarding contaminated sites, the Parliament specifies that decontamination of sites should always be considered as the first risk management measure. The Parliament does not (no more than the Commission proposal) set a timeline for prioritisation and remediation of contaminated sites. On other aspects of the Directive – sustainable soil management practices, land take – the Parliament weakens the Commission proposal by removing obligations for Member States and removes provisions on penalties for non-compliance.

European Parliament maintains main provisions on environmental risk assessments of medicinal products in adopted resolution

The European Parliament adopted its resolution on the pharmaceutical legislative package, consisting of a Directive and a Regulation, on 10 April 2024. The Parliament made only minor amendments to new provisions relating to environmental risk assessments (ERA) of medicinal products, maintaining the proposal from the Commission that the ERA must indicate whether the pharmaceutical product contains PBT, vPvB, PMT, vPvM, or endocrine active agents. The Parliament added a requirement to make the outcome of the ERA, including the data submitted by the marketing authorisation holder, public (with the exception of commercially confidential information). The incompleteness of the ERA or deficiencies in addressing environmental risks are kept as a ground for refusing the marketing authorisation. The Parliament also maintained the provision subjecting to medical prescription medicinal products containing active substances (or any adjuvant or constituent) that are PBT, vPvB, PMT or vPvM.

Key legislative files still open as parliamentary term ends

The last plenary session of the European Parliament on 22-25 April marked the end of the 2019-2024 legislative term. A number of legislative files have however not been concluded during this term. Discussions on the ‘one substance, one assessment’ package (common data platform and cooperation across EU Agencies) have only started in the Environment Committee with an exchange of views with the Commission in March. The work on the file will be carried out in the next legislative term. On a number of files, although the Parliament has adopted its position, the Council has not yet reached a general approach. If the Council adopts its general approach in the meantime, interinstitutional negotiations will take place in the new legislative term (files adopted by the Parliament in plenary normally remain valid). These files include the Soil Monitoring Directive, the pharmaceutical package, the Toy Safety Directive, and the revision of the water legislation (WFD, EQS Directive and Groundwater Directive). On this last file, the European Parliament voted to confirm their position (adopted in September 2023) during the last plenary session, avoiding the need to reopen the file in the next term.

The European Environmental Agency and ECHA publish the EU indicator framework for chemicals

The development of a framework of indicators to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation was announced in the Chemical Strategy for Sustainability. The indicator framework was published by the EEA as an online dashboard on 17 April 2024, accompanied by a synthesis report written jointly with ECHA. The indicator dashboard is composed of 25 quantitative indicators providing insights into the drivers and impacts of chemical pollution in the EU, complemented by 22 ‘signals’ providing additional insights or indicating trends for specific issues. The indicator framework aims to support the measurement of progress towards the policy objectives of the Chemicals Strategy for Sustainability, assist EU institutions in monitoring the effectiveness of chemicals legislation and help identify the need for future action.

Upcoming consultation deadlines:

  • Deadline to provide feedback on the draft recommendation for including Melamine in the Authorisation List: 7 May 2024
  • Deadline to provide feedback on the proposal for hazard classification of 1,3-diphenylguanidine: 17 May 2024.

More information of upcoming actions related to persistent and mobile substances

For more information of regulations under the regulatory watch, as well as a Gantt Chart of the roll out, continuously updated spreadsheet and more information, please visit